a practical approach to pharmaceutical policy

A Practical Approach to
Pharmaceutical Policy
Andreas Seiter
DIRECTIONS IN DEVELOPMENT
Human Development
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A Practical Approach to
Pharmaceutical Policy
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A Practical Approach to
Pharmaceutical Policy
Andreas Seiter
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© 2010 The International Bank for Reconstruction and Development / The World Bank
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ISBN: 978-0-8213-8386-5
eISBN: 978-0-8213-8387-2
DOI: 10.1596/978-0-8213-8386-5
Library of Congress Cataloging-in-Publication Data
Seiter, Andreas.
A practical approach to pharmaceutical policy / Andreas Seiter.
p. ; cm. — (Directions in development)
Includes bibliographical references and index.
ISBN 978-0-8213-8386-5 (alk. paper)
I. Pharmaceutical policy. I. World Bank. II. Title. III. Series: Directions in development
(Washington, D.C.)
[DNLM: 1. Drug Industry—organization & administration. 2. Developed Countries. 3. Government
Regulation. 4. Health Plan Implementation. 5. Health Policy—economics. QV 736 S462p 2010]
RA401.A1S45 2010
362.17'82—dc22
2010015420
Cover photo: istockphoto.com
Cover design: Naylor Design, Washington, D.C.
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v
Foreword xi
Preface xiii
Acknowledgments xv
About the Author xvii
Abbreviations xix
Chapter 1 Pharmaceutical Policy Goals 1
Pharmaceutical Policy Framework 3
Parameters for Monitoring the Effect and
Progress of Pharmaceutical Reforms 6
References 10
Chapter 2 Introducing the Stakeholders 11
Multinational Research-Based Companies 13
Multinational Generics Companies 18
National Generics Companies 21
Brokers 22
Procurement Agents 23
Importers and Agents 24
Wholesalers 25
Central Medical Stores 26
Contents
v
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vi Contents
Retail Pharmacists and Drug Sellers 27
Prescribers 28
Consumers 29
Public Policy Makers: Legislative and Executive 30
Regulatory and Executive Agencies 31
Expert Commissions and Advisers 32

Civil Society Organizations 32
International Agencies and Donors 33
Public Purchasers 35
Payers 35
Pharmaceutical Benefit Managers 36
Consultants 36
Notes 37
References 38
Chapter 3 Patterns of Dysfunction 39
Inadequate Regulation of Core Pharmaceutical
Sector Functions 41
Lack or Misuse of Funds 44
Ineffective or Inefficient Procurement 45
Dysfunctional Supply Chains 48
Corruption, Abuse of Public Funds, and
Unethical Business Practices 51
Inadequate Incentives for Providers and
Policy Makers 53
Medicine Prices Perceived as Too High 59
Conflicts between Innovation and Cost
Containment 66
Conflicts between Industrial Policy and
Public Health Objectives 71
Irrational or Inappropriate Use of Drugs 73
A Tool to Assess the Sector and Diagnose
Dysfunctions 75
Notes 77
References 78
Chapter 4 Key Elements of a Successful Pharmaceutical
Policy 81

Ensuring Access to Safe and Effective Drugs
through Well-Designed Supply Chains 82
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Using Purchasing Power to Get Value for Money 93
Managing the Decision Process on Formulary
Inclusion 97
Creating Adequate Information Systems 104
Ensuring Rational and Cost-Effective Use of
Medicines 107
Securing Adequate Financing and Payment
Mechanism for Pharmaceuticals 110
Reconciling Health Policy and Industrial Policy
in the Pharmaceutical Sector 113
Ensuring Good Governance of the Sector 117
Notes 120
References 121
Chapter 5 Policy Packages to Achieve Strategic
Long-Term Goals 123
Essential Medicines Policy 124
Generic Drugs Policy 126
Innovation-Friendly Drugs Policy 127
Combining Several Policy Models within
One Country 128
Notes 129
Reference 129
Chapter 6 Factors Influencing Policy Implementation 131
Stakeholder Assessment and Involvement 132
Strategies to Neutralize Political Opposition 135
Note 137
Reference 137

Chapter 7 Pharmaceutical Policy Illustrated in Country
Examples 139
Ghana: National Health Insurance as a
“Game Changer” 139
Lithuania: Dealing with the Effects of the
Financial Crisis 143
China: Improving Social Protection for the
Rural Poor 145
Russian Federation: Affordability and Access
to Essential Drugs 146
Contents vii
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Liberia: Building Up after Conflict 147
Notes 149
References 149
Chapter 8 Pharmaceutical Policy Outlook 151
Regulatory Framework 151
Drug Prices 153
Financing and Management of Drug Benefits 154
Effect on Markets and Industry 155
General Trend: Convergence toward Models
That Work 158
References 159
Appendix A A Tool to Assess the Pharmaceutical Sector
in a Given Country 161
Appendix B Customized Version of the Assessment Tool
(Appendix A) for Use in an Assessment of the
Pharmaceutical Sector in Turkey 167
Part 1: Quantitative Data 169
Part 2: Descriptive Section 171

Appendix C Assessment Tool for Government Procurement
Agencies in the Health Sector in India 175
Index 207
Boxes
1.1 Example of Target Setting in a Project Aimed at
Improving Access to Medicines in a Low-Income Country 8
2.1 A Tragedy in Panama, Caused by a Toxic Ingredient
in Cough Syrup 21
3.1 Major Cost Drivers for Ensuring Drug Availability
in Health Centers in Lesotho 50
3.2 Fraudulent Abuse of Health Insurance Funds in Germany 53
3.3 Example of Price Regulation in Practice 62
3.4 NICE: Example of an Institution Set Up to Manage
the Conflict between Innovation and Cost Containment
in Health Care 69
3.5 Access to Medicines and the TRIPs Agreement in Brazil 70
viii Contents
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4.1 Scope and Purpose of a Framework Contract 90
4.2 Creating a Secure Supply Chain in Liberia 93
4.3 Hypothetical Example of the Use of Purchasing Power
to Ensure Availability of Low-Price Drugs to Patients
with Health Insurance 95
4.4 Hypothetical Example of a Low-Cost Assessment
Process for New Drugs 101
4.5 Sample Format for Ranking Drug X for Treatment of
Acute Ischemic Stroke within the First 60 Minutes 103
6.1 Example of a Multistakeholder Process to Address
Controversial Policy Positions 134
Figures

1.1 Emergence of Core Pharmaceutical Policy Objectives
by Income Level 2
1.2 Hierarchy of Laws, Regulations, and Implementing
Agencies in the Pharmaceutical Sector 5
2.1 Evolution of the Pharmaceutical Sector in Countries
of Different Income Levels 13
3.1 Example of a Pharmaceutical Procurement Cycle 46
3.2 Incentives Influencing a Physician’s Prescribing Behavior 54
3.3 Components of the Retail Drug Price 60
4.1 Example of an Integrated Pharmaceutical Supply Chain 84
4.2 Example of a Public Sector Supply System 87
4.3 Collection of Prescribing and Drug Use Information at
the Pharmacy Level 105
5.1 Three Levels of Pharmaceutical Policy 124
5.2 Standard Elements of an Essential Medicines Policy 125
5.3 Standard Elements of a Generic Drugs Policy 126
5.4 Standard Elements of an Innovation-Friendly
Drugs Policy 128
6.1 Model Process to Secure Acceptance for a Difficult
Reform Project 136
7.1 Increase in Turnover of Revolving Drug Funds after
Introduction of NHIS in Ghana 141
Tables
2.1 Top-10 Pharmaceutical Companies by Sales, 2008 16
3.1 Links between Enforcement of Drug Regulation and
Access to Medicines 43
Contents ix
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3.2 Typical Problems in Pharmaceutical Procurement
and Their Consequences 47

3.3 Common Patterns of Irrational Drug Use and
Their Likely Causes 76
4.1 Negotiated Solutions to Limit Prices of Patented Drugs 96
4.2 Payer-Side Data for Decision Makers 105
4.3 Improving Rational Use of Medicines 108
4.4 Comparison between Government-Run Health Service
and Third-Party Fund 112
4.5 Industrial Policy versus Public Health Policy 116
4.6 Strategies for Dealing with Governance Issues in
Low- and Middle-Income Settings 119
6.1 Likely Stakeholder Positions toward a Reform That
Aims at Greater Compliance with Guidelines for
Rational Use of Drugs 133
7.1 Ghana: Pharmaceutical Sector Data, 2008 140
7.2 Pharmaceutical Sector Challenges in Ghana 142
8.1 Likely Trends in the Pharmaceutical Sector, 2010–20 158
xContents
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xi
Recent decades have seen miraculous progress in developing drugs and
medicines that save lives, treat illness, and protect families and communi-
ties from the devastating loss of parents and breadwinners. For people suf-
fering from HIV/AIDS, malaria, tuberculosis, and pneumonia, as well as
those with chronic diseases such as diabetes, cardiovascular disease, and
cancers, timely access to life-saving treatment can make the difference
between life and death or lasting disability.
Ensuring that people have the affordable, quality health care they need
for healthy lives is a cardinal policy goal for governments around the world.
To realize this goal, getting the details right is a complex process even by the
standards of the Organisation for Economic Co-operation and Develop-

ment, let alone in developing countries, where regulatory and pharmaceu-
tical capacity may be stretched. For example, the pharmaceutical “value
chain” that ensures that a patient gets the right medicine at the right time
may be weak or broken. Manufacturers may decide against investing in
developing or manufacturing new drugs for treating diseases that afflict
poor people if they do not see a market for their products. Even if a poten-
tial market exists, regulatory barriers and other inefficiencies may discour-
age manufacturers from marketing their drugs in certain countries or may
delay the launch of new medicines in others.
Foreword
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These potential breakdowns in the process show that pharmaceutical
markets are not self-regulating, unlike those for many common consumer
products. For example, policy makers must intervene frequently to set
standards and subsequently enforce them through licensing procedures.
They also need to provide financing in ways that counterbalance com-
mercial incentives and ensure that doctors, nurses, and their patients get
accurate information and knowledge about the medicines being pre-
scribed and taken. Low-income countries need effective regulatory and
distribution systems to make sure that donor aid for medicines can be
made available to as many people as possible. This is no small undertak-
ing. Consider that well-off middle-income countries’ resources are also
consistently under pressure to give their citizens wide access to the latest
drugs and medicines within their existing, limited, health budgets.
This publication offers a compact “pharmaceutical field guide” for
health and development policy makers in low- and middle-income coun-
tries. It offers analytical tools and practical advice, based on country case
studies, of how to lay the groundwork for advancing smart policy solu-
tions. The report also explores the political economy of reforms in the
pharmaceutical sector. As we know from experience worldwide, govern-

ments that try to rein in health care costs by curbing drug coverage can
face strenuous reactions.
As the world enters the five-year countdown to the 2015 Millennium
Development Goals, this report will provide advice for governments, pol-
icy makers, development partners, civil society organizations, and others
on the design and implementation of effective pharmaceutical policies—
an essential part of the effort to improve the health of poor people.
Julian Schweitzer
Director, Health, Nutrition and Population
The World Bank
xii Foreword
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xiii
There is no shortage of literature about pharmaceutical regulation, pric-
ing, financing, reimbursement, procurement, distribution, and all the
other aspects that together define the pharmaceutical policy framework
in a given country. However, what appears to be lacking is a “practitioner’s
guide” for navigating the complex field of pharmaceutical policy while
considering the various challenges and limitations that characterize polit-
ical reality.
Obviously, no “one size fits all” approach applies to pharmaceutical
policy. Even two countries with similar objectives may need different sets
of policies, depending on their starting position, preexisting laws and reg-
ulations, perceptions among providers and patients, and implementation
capacity. Although high-income countries may find industrial policy and
innovativeness hard to reconcile with cost containment in the health sec-
tor, choices may be even harder for middle-income countries that have to
bridge the divide between a demanding urban population and large num-
bers of poor people in peri-urban and rural areas. Many low-income
countries are struggling to provide basic essential drugs to their popula-

tions through still largely state-run delivery systems.At the same time, the
growing private markets in these countries may be flooded with drugs
of questionable origin and quality. In each case, policy makers and the
Preface
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implementing agencies need to select and combine their policy measures
in a way that not only addresses the main problems conceptually but also
is practically viable and sustainable.
This book discusses the wide range of challenges faced by policy mak-
ers in the pharmaceutical sector, presents the current know-how in terms
of policy measures, and provides specific examples of policy packages that
can be used in defined circumstances, even if one assumes a certain degree
of political resistance and capacity limits on the side of the implementing
agency. This book focuses on developing countries and tries to address the
issues faced by both low- and middle-income countries.The book does not
cover the vaccines market and its respective policies because too many dif-
ferences exist between the markets for vaccines and pharmaceuticals to
cover both subsectors in one publication of this type.
The book ends with an outlook on how things might evolve in the
longer term. It assumes that some form of convergence will take place
toward “models that work,” thus reducing the fragmentation of policies
and enhancing regulatory and economic efficiencies over time—one hopes
to the benefit of all stakeholders in the sector and, in particular, those
who, as patients, currently do not have reliable access to effective and safe
medicines.
Who should read this book?
• Practitioners in national administrations, government agencies, insur-
ance funds, and other bodies that deal with pharmaceuticals on a reg-
ular or occasional basis
• Staff members and consultants of international organizations, health

sector nongovernmental organizations, and other professionals
involved in health projects with a pharmaceutical component
• Academics and students in the field of public health and health eco-
nomics
• Private sector professionals and all others interested in a better under-
standing of the complex pharmaceutical sector.
xiv Preface
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xv
The following World Bank colleagues provided guidance and input during
the concept stage of this book: Ekkehard Betsch, Mukesh Chawla, Heba
Elgazzar, Armin Fidler, G. N. V. Ramana, Finn Schleimann, Juan Pablo
Uribe, and Abdo Yazbeck. Peer reviewers for the book were Armin Fidler
and Pia Helene Schneider, both of the World Bank.
The author would like to thank the following individuals for their
thorough chapter reviews and constructive critiques, which helped cor-
rect several errors and omissions and provided many ideas about how to
make this book more useful to its readers:
• Ekkehard Betsch (World Bank) and Juergen Reinhardt (UNIDO),
the discussion of conflicts between industrial and health policies in
chapters 3 and 4
• Kalipso Chalkidou (National Institute of Clinical Excellence), the
discussion of innovation-induced cost pressures in chapter 3 and the
discussion of decision making on formulary inclusion in chapter 4
• Agnes Couffinal (World Bank), the discussion of incentives and use
of purchasing power in chapters 2, 3, and 4 and the Lithuanian case
described in chapter 7
• Kees de Joncheere (World Health Organization Regional Office for
Europe), chapter 5 on policy packages
Acknowledgments

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• Henk den Besten (I+ Solutions) and Prashant Yadav (MIT-Zaragoza
Logistics Center), the discussions of procurement, logistics, and supply
chains in chapters 2, 3, and 4
• Richard Laing (World Health Organization), the discussion of drug
pricing in chapter 3
• Ruth Lopert (Australian Therapeutic Goods Administration), chapter 8
on the pharmaceutical policy outlook
• Patricio Marquez (World Bank), chapter 1 on policy goals, chapter 2 on
stakeholders, and the Russian Federation case described in chapter 7
• Andre Medici and Fernando Montenegro Torres (both World Bank),
the section on regulation in chapter 3
• Zafar Mirza (World Health Organization Eastern Mediterranean
Regional Office), the discussion of rational use of medicines in
chapters 3 and 4
• Dena Ringold (World Bank), the discussions of corruption and gover-
nance in chapters 3 and 4, the dysfunction overview in chapter 3, and
the introduction to the assessment tool in appendixes A and B
• Karima Saleh, Yi-Kyoung Lee, and Shuo Zhang, the country examples
featuring China, Ghana, and Liberia in chapter 7
• Juan Pablo Uribe (World Bank), chapter 6 on implementation
• Anita Wagner (World Health Organization Collaborating Center on
Pharmaceutical Policy at Harvard Medical School), the sections cov-
ering funding and financing issues related to health insurance in
chapters 3 and 4.
Sincere thanks go to Ekkehard Betsch, Elizabeth Nyamayaro, and Sally
Schlippert, who assisted with research and provided support for the
preparation, review, editing, and production process.
xvi Acknowledgments
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xvii
Andreas Seiter is a senior health specialist at the World Bank’s Health,
Nutrition, and Population Anchor. A medical doctor trained in Germany,
Seiter worked for 18 years in the pharmaceutical industry before joining
the World Bank in 2004. He is responsible for the World Bank’s analytical
and advisory work in all areas of pharmaceutical policy, such as regulation,
governance, quality assurance, financing, purchasing, supply chain, and
rational use. He has worked with World Bank teams, policy makers, and
experts in several Bank client countries in Africa, Eastern Europe, Latin
America, the Middle East, and South Asia.
About the Author
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xix
A4R Accountability for Reasonableness
AIDS acquired immunodeficiency syndrome
AI
.
FD Aras¸tırmacı I
.
laç Firmaları Derneg˘i, or Association of
Research-Based Pharmacies (Turkey)
AMFm Affordable Medicines Facility—malaria
API active pharmaceutical ingredient
ATC anatomical therapeutic chemical (classification)
cGMP current good manufacturing practice
CIF customs, insurance, and freight
CMS central medical store
COP community outreach pharmacy
DALY disability-adjusted life years

EFPIA European Federation of Pharmaceutical Industries and
Associations
EU European Union
FDA U.S. Food and Drug Administration
FOB free on board
GLP good laboratory practice
GMP good manufacturing practice
HIF health insurance fund
Abbreviations
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HIV human immunodeficiency virus
ICB international competitive bidding
IEIS I
.
laç Endüstrisi I
.
s¸verenler Sendikası, or Pharmaceutical
Manufacturers Association of Turkey
IFPMA International Federation of Pharmaceutical Manufacturers and
Associations
IMS company that provides pharmaceutical market data in
developed and middle-income markets
INN international nonproprietary name
IT information technology
KEMSA Kenya Medical Supplies Agency
MeTA Medicines Transparency Alliance
MOH ministry of health
MSH Management Sciences for Health
NCB national competitive bidding
NDS National Drug Service (Liberia)

NDSO National Drug Service Organization (Lesotho)
NGO nongovernmental organization
NHIS National Health Insurance Scheme (Ghana)
NHS U.K. National Health Service
NICE National Institute of Clinical Excellence (United Kingdom)
ÖBIG Österreichisches Bundesinstitut im Gesundheitswesen, or
Austrian Health Institute
OECD Organisation for Economic Co-operation and Development
OTC over the counter
PBM pharmaceutical benefit manager
PBS Pharmaceutical Benefits Scheme (Australia)
PER Public Expenditure Review
PETS pharmaceutical expenditure tracking system
PFSA Pharmaceutical Fund and Supply Agency (Ethiopia)
PPRI Pharmaceutical Pricing and Reimbursement Information
(initiative)
PSA procurement services agency
QALY quality-adjusted life year
R&D research and development
Rx prescription drugs
SDRA state drug regulatory authority
SOP standard operating procedure
SPF State Patient Fund (Lithuania)
SSI Social Security Institution
xx Abbreviations
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TRIPs Trade-Related Aspects of Intellectual Property Rights
(agreement)
UN United Nations
UNICEF United Nations Children’s Fund

VAT value added tax
WHO World Health Organization
Abbreviations xxi
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1
Policy, for the purposes of this book, is defined as the conscious attempt
of public officials or executives entrusted with public funds to achieve
certain objectives through a set of laws, rules, procedures, and incentives.
With regard to pharmaceutical policy, the first question has to be “What
are these objectives?”
The answer varies for countries of different income levels (see figure 1.1).
For low-income countries, the most common objective is to secure the
population’s access to medicines necessary to achieve major public health
goals. Such goals might include reducing maternal and child mortality or
reducing death rates from AIDS, malaria, and tuberculosis.
Middle-income countries also must secure access to medicines for
basic public health programs for the poor, who represent the majority of
the population; however, these countries need to consider the demands of
a wealthier urban population as well. The urban middle class in Beijing,
São Paulo, or Bangalore increasingly enjoys a lifestyle similar to the mid-
dle class in high-income countries and expects access to a broader range
of drugs than just essential medicines. This demand for innovative and
more expensive drugs needs to be balanced against the limited funding
available from public budgets or insurance funds, which tends to lag the
growth of private incomes.
CHAPTER 1
Pharmaceutical Policy Goals
What Do Policy Makers Want to Achieve?
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Most middle-income countries and several low-income countries have
a domestic drug industry. For those countries, policy makers are pressured
to ensure the prosperity of this industry, in particular if it is a significant
factor in the national economy (as is the case in India and Jordan). This
pressure creates conflicts with policy objectives that are based on public
health goals: overprescribing and use of more expensive drugs are good
for the profitability of the industry but bad for public health and public
budgets.
In middle-income countries, pressure does not come from domestic
manufacturers only but also from multinational companies. Occasionally,
the trade representatives of their home countries support these compa-
nies; in negotiations of broader trade agreements, such representatives may
be able to undermine domestic policy initiatives aimed at cost contain-
ment in the health sector by limiting access to expensive imported drugs.
Pressure also comes from patient organizations and consumers, who
through the Internet can access information on innovative treatment
choices and demand that they be made available. Given the sophisticated
cost-containment tools applied in developed countries, which still consti-
tute the main markets for multinational drug companies in terms of size,
middle-income countries have become the dominant markets for ensuring
top-line growth for multinational companies. These companies, therefore,
2 A Practical Approach to Pharmaceutical Policy
Figure 1.1 Emergence of Core Pharmaceutical Policy Objectives by Income Level
High-income countries
Universal access to all important treatments and support
for innovation through research and development of
new drugs and treatments
Middle-income countries
Access to a broader range of
medicines, pooled financing

mechanisms, and industrial
development in the pharmaceutical
sector
Low-income countries
Access to quality
essential
medicines
Source: Author’s representation.
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